Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA, SCULPTRA AESTHETIC

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR™ MemoryGel™ Enhance Breast Implants

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR™ MemoryGel™ Enhance Breast Implants

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE/AORTOILIAC ENDOGRAFT SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL NT HEMOSTATIC MATRIX

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·KONTUR 55 EW

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicon-Filled Breast Implants

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera™ System

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator